Rotator Cuff Solution R Combined Strengths. Precise Control. TWINFIX Ultra FOOTPRINT Ultra Suture Anchors
Trusted materials Absorbable Our absorbable HA suture anchor combines poly-l-lactic acid (PLLA) with hydroxyapatite (HA), a calcium phosphate similar to the mineral compound of bone. Once absorbed, it has the fracture resistance of human cortical bone.* HA is a natural bone mineral shown to promote bone replacement. Non-absorbable Our non-absorbable PK suture anchor incorporates PEEK-OPTIMA polymer from Invibio. With a modulus similar to cortical bone, PEEK-OPTIMA exhibits an ideal combination of strength, biocompatibility, revisability and inherent radiolucent characteristics. Metallic Titanium (Ti) suture anchors exhibit ideal fixation strength and anchor stability. Catering to surgeon s preference, titanium material brings a reliable solution that caters to both the needs of the patient and surgeon. * Akao, M., Aoki, H. and Kato, K., Mechanical properties of sintered hydroxyapatite for prosthetic applications. Journal of Material Science: 16, 809-812, (1981).
Procedural Techniques STEP 1: Identify the rotator cuff tear and confirm the rotator cuff tissue is mobile. Prepare the repair site utilizing the Whirlwind RF probe to remove any excess tissue from the articular margin of the humeral head to ensure proper visualization of the hole preparation site. STEP 5: Select the appropriate limb(s) of suture(s) from the TWINFIX Ultra PK medial row suture anchors. Thread the free medial row suture ends through the FOOTPRINT Ultra PK suture anchor using the blue suture threading loop STEP 2: Use the 3.8 mm Tapered Awl (or recommended hole preparation device based on anchor material and bone quality) to prepare an anchor hole at the desired site on the medial border of the rotator cuff footprint which is slightly lateral to the articular margin. The proper hole depth is achieved when the laser depth mark on the distal end of the awl contacts the bone surface STEP 6: Establish and maintain axial alignment of the suture anchor to the prepared insertion site, and place the tip of the anchor into the prepared hole. Using a mallet tap the FOOTPRINT Ultra PK suture anchor inserter handle until the laser mark is flush with the cortical bone. STEP 3: Insert the TWINFIX Ultra PK suture anchor at a 45 degree angle, so it is partially under the articular surface. Insert by twisting the anchor until the laser mark is flush with the cortical bone layer. This places the suture anchor approximately 1 mm below the bone surface. Repeat this process to place a second TWINFIX Ultra PK suture anchor. Use a Smith & Nephew ELITE PASS Suture Shuttle to pass sutures through the rotator cuff from an anterior to posterior position, then tension and tie the sutures as desired. STEP 4: Place the distal tip of the awl/drill onto the bone at the desired implantation site of the FOOTPRINT Ultra PK suture anchor at or slightly distal to the lateral margin. Hold the awl in place and use a mallet to tap the proximal end to prepare the insertion site. The proper hole depth is achieved when the laser depth mark on the distal end of the awl contacts the bone surface. STEP 7: Apply tension to each free limb of suture individually to establish the desired suture tension over the rotator cuff tissue and secure suture limbs on the inserter handle suture management tabs. While maintaining slight downward pressure on the inserter handle turn the torque limiter knob in the clockwise direction until audible clicks are heard locking the suture within the anchor body STEP 8: Slowly disengage the suture anchor from the inserter by pulling straight back or tapping the distal end with a mallet. Cut the excess suture.
Ordering Information Reference # Description Reference # Description TWINFIX Ultra PK Suture Anchor 72202595 TWINFIX Ultra PK 4.5 mm Anchor with two #2 sutures 72202623 TWINFIX Ultra PK 4.5 mm Anchor with two #2 sutures 72202599 TWINFIX Ultra PK 5.5 mm Anchor with two #2 sutures 72202625 TWINFIX Ultra PK 5.5 mm Anchor with two #2 sutures 72202600 TWINFIX Ultra PK 5.5 mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) sterile 72202605 TWINFIX Ultra PK 6.5 mm Anchor with two #2 sutures 72202630 TWINFIX Ultra PK 6.5 mm Anchor with two #2 sutures 72202606 TWINFIX Ultra PK 6.5 mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) sterile Instruments 72202621 3.8 Tapered Awl Disposable for use with general hole preparation for normal bone quality 72201915 3.8 Tapered Awl Reusable for use with general hole preparation for normal bone quality 72202633 4.5 Awl Dilator for use with 4.5 mm Anchor hole 72202634 5.5/6.5 Awl Dilator for use with 5.5/6.5 mm Anchor hole 72202116 3.5 mm Spade Tip Drill for use with 4.5 mm Anchor hole 72201707 4.5 mm Spade Tip Drill for use with 5.5 mm Anchor hole 72201708 5.5 mm Spade Tip Drill for use with 6.5 mm Anchor hole TWINFIX Ultra HA Suture Anchor 72202597 TWINFIX Ultra HA 4.5 mm Anchor with two #2 sutures 72202624 TWINFIX Ultra HA 4.5 mm Anchor with two #2 sutures 72202602 TWINFIX Ultra HA 5.5 mm Anchor with two #2 sutures 72202626 TWINFIX Ultra HA 5.5 mm Anchor with two #2 sutures 72202603 TWINFIX Ultra HA 5.5 mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) 72202608 TWINFIX Ultra HA 6.5 mm Anchor with two #2 sutures 72202631 TWINFIX Ultra HA 6.5 mm Anchor with two #2 sutures 72202610 TWINFIX Ultra HA 6.5 mm Anchor with three #2 sutures w(white, COBRAID-blue, COBRAID-black) Instruments 72202633 4.5 Awl-Dilator for use with 4.5 mm Anchor hole preparation 72202634 5.5/6.5 Awl-Dilator for use with 6.5 mm Anchor hole preparation 72202116 3.5 mm Spade Tip Drill for use with 4.5 mm Anchor hole 72201707 4.5 mm Spade Tip Drill for use with 5.5 mm Anchor hole 72201708 5.5 mm Spade Tip Drill for use with 6.5 mm Anchor hole TWINFIX Ultra Ti Suture Anchor 72202893 TWINFIX Ultra Ti 4.5 mm Anchor with two #2 sutures 72202894 TWINFIX Ultra Ti 4.5 mm Anchor with two #2 sutures 72202895 TWINFIX Ultra Ti 5.5 mm Anchor with two #2 sutures 72202896 TWINFIX Ultra Ti 5.5 mm Anchor with two #2 sutures 72202897 TWINFIX Ultra Ti 5.5 mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) 72202898 TWINFIX Ultra Ti 6.5 mm Anchor with two #2 sutures 72202899 TWINFIX Ultra Ti 6.5 mm Anchor with two #2 sutures 72202900 TWINFIX Ultra Ti 6.5 mm Anchor with three #2 sutures (white, COBRAID-blue, COBRAID-black) Instruments 72202116 3.5 mm Spade Tip Drill for use with 4.5 mm Anchor hole 72201707 4.5 mm Spade Tip Drill for use with 5.5 mm Anchor hole 72201708 5.5 mm Spade Tip Drill for use with 6.5 mm Anchor hole 72202621 3.8 mm Tapered Awl-Disposable 72201915 3.8 mm Tapered Awl-Reusable FOOTPRINT Ultra PK Suture Anchor 72202901 FOOTPRINT Ultra 4.5 mm Suture Anchor 72202902 FOOTPRINT Ultra 5.5 mm Suture Anchor Instruments 72202621 3.8 mm Tapered Awl-Disposable 72201915 3.8 mm Tapered Awl-Reusable 72202116 3.5 mm Spade Tip Drill for use with the 4.5 mm Anchor hole 72201707 4.5 mm Spade Tip Drill for use with the 5.5 mm Anchor hole 72201450 3.8 mm Straight Awl-Reusable 72202986 3.8 mm Straight Awl-Disposable SHOULDER ARTHROSCOPY INSTRUMENTATION 72202503 ELITE PREMIUM II Shoulder Arthroscopy System 7211020 ELITE PASS Premium Arthroscopic Suture Shuttle with Ratchet EA 7211021 ELITE PASS Premium Arthroscopic Suture Shuttle without Ratchet EA 72201840 ELITE PASS Long Bite EA 7210693 ELITE PASS Shuttle Needle, box of 5, sterile BX 72202589 Suture Cutter EA RESECTION 7205962 DYONICS BONECUTTER ELECTROBLADE Resector 5.5 mm, sterile 3/BX 72202213 DYONICS BONECUTTER ELECTROBLADE Resector 4.5 mm, sterile 3/BX 7210380 VULCAN Generator Adaptor, non-sterile, reusable 72202139 DYONICS RF-S WHIRLWIND 90 degree Probe; 3.75 mm shaft; 90 degree shaft angle 72202149 DYONICS Generator System Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA www.smith-nephew.com T +1 978 749 1000 US Customer Service: +1 800 343 5717 International Customer Service: +1 978 749 1140 PATIENT POSITIONING 7210996 T-Max System BX 7210994 SPIDER System (Beach Chair) BX 7210995 SPIDER System (Lateral Decubitus) BX 72201428 Lateral Jack EA 72202466 Lateral Jack, sterile cover, box of 25 BX Trademark of Smith & Nephew. Certain marks Reg US Pat & TM Off. All trademarks acknowledged. 2010 Smith & Nephew, Inc. All rights reserved. Printed in USA. 09/10 10600547 Rev. C
Two Anchors. One precisely controlled rotator c Shoulder surgeons can rely on Smith & Nephew for rotator cuff repair solutions that provide easy, secure and strong repairs with precise control over final tensioning. This two anchor solution combines the benefits of our newest shoulder anchors, the TWINFIX Ultra and FOOTPRINT Ultra Suture Anchors. Reduce Cuff Displacement and Suture Slippage with a customizable repair By combining the individual strengths of each anchor product into one solution we ve created a customizable repair that facilitates complete rotator cuff footprint control. Strong pullout strength in the medial row with suture security and the ability to tension in the lateral row means a solution that can help reduce cuff displacement and suture slippage.* *Data on file at Smith & Nephew. ITR-3679, 2008
TWINFIX Ultra PK TWINFIX Ultra Ti TWINFIX Ultra HA cuff solution. TWINFIX Ultra Suture Anchor Medial Row solutions with TWINFIX Ultra Suture Anchors Available in a choice of non-absorbable PEEK, absorbable HA, and titanium materials, as well as in a variety of size options and a choice of suture configurations, TWINFIX Ultra suture anchors can be used for primary or double row repairs and for the medial row of a suture bridging technique. Ideal Fixation Strength: Transitional thread design provides secure fixation with distal cutting threads for easier insertion and proximal locking threads for stronger pull-out strength, even in poor bone quality. 1 ULTRABRAID suture provides stronger knot strength than competitive suture and a low profile knot stack. 2 Internal driver supports anchor to optimize force transfer during insertion into all qualities of bone. Optimal Versatility: Numerous anchor sizes, 4.5 mm, 5.5 mm and 6.5 mm facilitates rotator cuff repairs in patients. Multiple suture configurations, with double or triple ULTRABRAID sutures, provides flexibility for surgeon. HA and PK: Multiple hole preparation instruments to address differing humeral bone quality. Ti: Elongated distal trocar tip allows anchor to be selftapping; without the need to predrill in most bone qualities Average Fixation Strength 1 25/5 pcf bone block lbf 70 60 50 40 30 20 10 0 PK 5.5 mm Smith & Nephew TWINFIX Ultra Mitek TM Healix TM PK Arthrex TM Corkscrew TM FT PK HA 5.5 mm Ti 5.5 mm 1) Data on file at Smith & Nephew, ITR-4091, ITR-4039, ITR-3952, 2009 2) Lo, Burkhart, Chan, and Kyriacos Athanasiou, Arthroscopic Knots: Determining the Optimal Balance of Loop Security and Knot Security, Arthroscopy 20, no. 5 (May-June 2004): 489-502
footprint Ultra Suture Anchor Lateral row solutions with FOOTPRINT Suture Anchors Available in two sizes, 4.5 and 5.5, the FOOTPRINT Ultra PK anchor is intended for use in the lateral row in double row suture bridging techniques. Uniquely designed, inner plug adjustability means more precise fixation and suture tensioning of final repair Reduced suture slippage means less gap formation and rotator cuff displacement 3 Exclusive tap-in anchor design with offset barbed geometry threads means strong pullout and easy insertion. 3 Average Fixation Strength 4 25/5 pcf bone block Torque Limiter Incorporates positive stop technology to drive the inner plug a specific distance confirming suture is secured within anchor body Elongated Handle Ergonomic handle designed for surgeon comfort and ease of use Integrated Suture Management Ergonomic and easy to use suture docking tabs for final suture tensioning 35 30 25 Hidden Retention Suture Runs parallel to the inserter and adds stability to the anchor/ inserter interface lbf 20 15 10 5 0 4.5 mm 5.5 mm 5.5 mm Smith & Nephew FOOTPRINT Ultra PK Arthrex TM PEEK PushLock TM Arthrex TM PEEK Swivel-Lock TM 3) Data on file at Smith & Nephew, ITR-3679, 2008 4) Data on file at Smith & Nephew, ITR-4202, 2010; ITR-3557, 2007; ITR-3784, 2008
Offset Barbed Geometry Unique barbed anchor design provides optimal pull-out strength for a tap-in anchor design Preferred Anchor Size 4.5 mm and 5.5 mm anchor size offerings accommodate a variety of repair techniques